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Volume 31, Number 2—February 2025
Online Report

Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics

Josephine BournerComments to Author , Michel Vaillant, Alex Paddy Abdel Salam, Marie Jaspard, Camille Fritzell, Shevin T. Jacob, Tom E. Fletcher, Michael Ramharter, Nnennaya Ajayi, Sylvanus Okogbenin, Cyril Erameh, Donald Grant, Robert Samuels, Oladele Oluwafemi Ayodeji, Armand Sprecher, Bronner P. Gonçalves, Tansy Edwards, Piero Olliaro, and the WALC Work Package 2 Working Group
Author affiliation: University of Oxford, Oxford, UK (J. Bourner, A.P.A. Salam, B.P. Gonçalves, P. Olliaro); Luxembourg Institute of Health, Strassen, Luxembourg (M. Vaillant); Sorbonne Université, Paris, France (M. Jaspard); St Antoine Hospital, Paris (M. Jaspard); The Alliance for International Medical Action, Dakar, Senegal (M. Jaspard); Inserm, Bordeaux, France (C. Fritzell); Liverpool School of Tropical Medicine, Liverpool, UK, S.T. Jacob, T.E. Fletcher); University Medical Center Hamburg-Eppendorf, Hamburg, Germany (M. Ramharter); German Center for Infection Research, Riems, Germany (M. Ramharter); Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria (N. Ajayi); Irrua Specialist Teaching Hospital, Irrua, Nigeria (S. Okogbenin, C. Erameh); Kenema General Hospital, Kenema, Sierra Leone (D. Grant, R. Samuels); Federal Medical Centre, Owo, Nigeria (O.O. Ayodeji); Médecins sans Frontières, Brussels, Belgium (A. Sprecher); London School of Hygiene and Tropical Medicine, London, UK (T. Edwards)

Main Article

Table 4

Composite primary end point for adaptive phase II/III randomized controlled platform trial to evaluate multiple Lassa fever therapeutics

Parameter (any of the following) Measurement definition Assessment time point*
Death
 1) Yes, 2) No
 Days 1–28
New onset of acute kidney injury KDIGO 3 (https://kdigo.org) Day 1: hospital discharge
New onset of acute respiratory failure Arterial oxygen partial pressure/fractional inspired oxygen <315 (21) based on 2 consecutive measurements taken >4 h apart meeting the above criteria
New onset of shock Mean arterial pressure <65 mm Hg (22) based on 2 consecutive measurements taken >4 h apart meeting the above criteria

*Events will be evaluated on day 1 after treatment initiation.

Main Article

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Page updated: January 21, 2025
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